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Chronic Obstructive Pulmonary Disease (COPD)IMT-COPDNCT07604961

Short-Term Inspiratory Muscle Training and Aerobic Exercise in Women With COPD

A study testing Inspiratory Muscle Training and Aerobic Exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mehmet İsmail TOSUN at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Brief Summary: This randomized controlled trial evaluated the short-term effects of inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, placebo inspiratory muscle training, and usual care in women with stable chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 48 to 65 years, women only
What is being tested?
Inspiratory Muscle Training and Aerobic Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Apr 2026to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged between 48 and 65 years Diagnosis of stage I or II chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria Stable COPD status No acute exacerbation within the previous six weeks Attending routine follow-up at the Chest Diseases Outpatient Clinic Non-use of tobacco products, including cigarettes, hookah, and other tobacco derivatives No medical condition that could interfere with safe exercise performance, such as serious cardiovascular, neurological, rheumatologic, orthopedic, or systemic disorders Ability to understand and communicate in Turkish No regular physical activity within the preceding three months, defined as moderate- to high-intensity exercise at least three days per week Voluntary participation with signed written informed consent

Who cannot join

  • Unstable COPD Acute COPD exacerbation within the previous six weeks Current tobacco use Medical contraindications to exercise, such as congestive heart failure, severe osteoarthritis, or advanced neurological disease Use of long-term home oxygen therapy Difficulty reading or comprehending Turkish Previous engagement in structured exercise either professionally or recreationally, including competitive athletes or individuals with formal exercise training Failure to attend at least three scheduled intervention sessions during the study period

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit University Çorum Erol Olçok Training and Research Hospital

    Çorum, Çorum, 1900

Other trials in Turkey (Türkiye)

About this study

Official title: Short-Term Inspiratory Muscle Training, Aerobic Exercise, and Detraining in Women With COPD: A Randomized Controlled Trial

Brief Summary:

This randomized controlled trial evaluated the short-term effects of inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, placebo inspiratory muscle training, and usual care in women with stable chronic obstructive pulmonary disease (COPD). The study aimed to determine whether these interventions improve respiratory muscle strength, pulmonary function, walking capacity, dyspnea, and psychological well-being after a four-week intervention period. A secondary aim was to examine whether any improvements were maintained during a two-week detraining period after supervised training was stopped.

Read more

Participants were randomly assigned to one of five groups: control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, or placebo inspiratory muscle training. Outcomes were assessed at baseline, after the four-week intervention, and on days 7 and 14 after the intervention. The main outcome was the change in maximal inspiratory pressure. Secondary outcomes included maximal expiratory pressure, peak inspiratory flow rate, inspiratory volume, forced vital capacity, forced expiratory volume in one second, six-minute walk distance, dyspnea, and well-being.

The study hypothesis was that inspiratory muscle training, either alone or combined with aerobic exercise, would improve respiratory muscle function, functional capacity, dyspnea, and well-being in women with COPD, and that the magnitude and persistence of these effects would differ between intervention groups.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is associated with airflow limitation, respiratory symptoms, reduced exercise tolerance, dyspnea, and impaired quality of life. In women with COPD, symptom burden and dyspnea may be more pronounced even at comparable levels of airflow limitation. Inspiratory muscle dysfunction may further contribute to breathing difficulty and reduced functional capacity. Therefore, interventions targeting inspiratory muscle performance may provide clinically relevant benefits in this population.

This single-center randomized controlled trial was designed to compare the effects of different short-term rehabilitation approaches in women with stable COPD. Participants were allocated to one of five parallel groups: usual care control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training plus aerobic exercise, or placebo inspiratory muscle training. The intervention period lasted four weeks, followed by a two-week detraining period during which supervised training was discontinued.

The inspiratory muscle training intervention used individualized resistance based on each participant's maximal inspiratory pressure, while the aerobic exercise intervention consisted of supervised treadmill walking at submaximal intensity. The combined group received both inspiratory muscle training and aerobic exercise. The placebo inspiratory muscle training group followed a similar breathing exercise procedure but with a low resistance load. The control group continued usual medical care without supervised exercise training.

The study was conducted at Hitit University Çorum Erol Olçok Training and Research Hospital. Assessments were performed before the intervention, immediately after the four-week intervention, and during follow-up on days 7 and 14 after the intervention. These follow-up measurements were included to examine whether the effects of training were maintained or reduced after the supervised intervention ended. The study focused on respiratory muscle performance, pulmonary function, walking capacity, perceived dyspnea, and psychological well-being in women with stable COPD

Being tested
Inspiratory Muscle Training, Aerobic Exercise, Placebo Inspiratory Muscle Training
Keywords
Inspiratory Muscle Training, Aerobic Exercise, Detraining, Respiratory Muscle Strength, Maximal Inspiratory Pressure, Pulmonary Rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory Muscle TrainingDevice

    Inspiratory muscle training was performed using the POWERbreathe Classic Light Resistance device. Participants trained three days per week for four weeks at a resistance corresponding to 40% of their individual maximal inspiratory pressure. Each session consisted of two sets of 30 repetitions in the seated position under supervision.

  • Aerobic ExerciseBehavioural

    Also called Supervised Treadmill Walking, Submaximal Aerobic Exercise

    Aerobic exercise consisted of supervised treadmill walking performed three times per week for four weeks. Each session included a 5-minute warm-up with low-intensity walking and breathing exercises, a 30-minute main exercise phase, and a 5-minute cool-down with slow walking. Exercise intensity was maintained at 50-65% of the participant's age-predicted maximal heart rate and monitored using an optical heart rate sensor. Treadmill speed was adjusted to keep heart rate within the target range, and perceived exertion was maintained at 4 to 6 on the Borg scale. Oxygen saturation, heart rate, and dyspnea were monitored throughout the sessions.

  • Placebo Inspiratory Muscle TrainingDevice

    Placebo inspiratory muscle training was performed using the same POWERbreathe Classic Light Resistance device and the same session structure as the true inspiratory muscle training intervention. The resistance was set at 15% of individual maximal inspiratory pressure.

Study groups in NCT07604961
Study groupRoleWhat they receive
ControlNo interventionParticipants in the control group continued their usual medical care and did not receive supervised inspiratory muscle training or aerobic exercise during the four-week intervention period. They were instructed to maintain their usual daily activities and not to start any new structured exercise program.
Inspiratory Muscle TrainingExperimentalParticipants performed supervised inspiratory muscle training three days per week for four weeks using the POWERbreathe Classic Light Resistance device. Training was performed at 40% of individual maximal inspiratory pressure and consisted of two sets of 30 repetitions per session.
Receives: Device: Inspiratory Muscle Training
Aerobic ExerciseExperimentalParticipants performed supervised aerobic exercise three days per week for four weeks. Each session consisted of treadmill walking at submaximal intensity, including warm-up, 30 minutes of main exercise, and cool-down. Exercise intensity was maintained at 50-65% of age-predicted maximal heart rate.
Receives: Behavioral: Aerobic Exercise
Combined Inspiratory Muscle Training and Aerobic ExerciseExperimentalParticipants received both supervised inspiratory muscle training and aerobic exercise three days per week for four weeks. Inspiratory muscle training was performed at 40% of individual maximal inspiratory pressure, with one set completed before and one set after the aerobic exercise session.
Receives: Device: Inspiratory Muscle Training; Behavioral: Aerobic Exercise
Placebo Inspiratory Muscle TrainingPlacebo comparatorParticipants followed the same inspiratory muscle training procedure as the true inspiratory muscle training group, using the same device and session structure. However, the device resistance was set at 15% of individual maximal inspiratory pressure.
Receives: Device: Placebo Inspiratory Muscle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maximal Inspiratory Pressure

    Maximal inspiratory pressure was assessed as an indicator of inspiratory respiratory muscle strength. Measurements were performed using the Micro Medical/CareFusion MicroRPM device. Participants performed maximal inspiratory efforts from residual volume in a seated position while wearing nose clips. At least three trials were performed, and the highest valid value was used for analysis.

    Measured: Baseline and immediately after the 4-week intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start6 Apr 2026
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to one of five parallel groups: control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, or placebo inspiratory muscle training. Each group followed its assigned condition during the four-week intervention period, followed by a two-week detraining period.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07604961
Sponsor's protocol ID
2026-08
Acronym
IMT-COPD
Status last verified
May 2026
First submitted
17 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared due to participant confidentiality and ethical restrictions. Aggregate study findings may be shared in scientific publications.

Publications

  • Eser E, Cevik C, Baydur H, Gunes S, Esgin TA, Oztekin CS, Eker E, Gumussoy U, Eser GB, Ozyurt B. Reliability and validity of the Turkish version of the WHO-5, in adults and older adults for its use in primary care settings. Prim Health Care Res Dev. 2019 Jul 1;20:e100. doi: 10.1017/S1463423619000343.

    PubMed 32800004
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PubMed 12091180
  • Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

    PubMed 31613151
  • Beaumont M, Forget P, Couturaud F, Reychler G. Effects of inspiratory muscle training in COPD patients: A systematic review and meta-analysis. Clin Respir J. 2018 Jul;12(7):2178-2188. doi: 10.1111/crj.12905. Epub 2018 May 23.

    PubMed 29665262
  • Yilmaz YA, Tosun MI, Demirkan E, Efdal A, Boyaci H, Arici IE, Yildiz YA, Gunaydin HK, Arici M, Markovic M, Kowalski T. Short-term inspiratory muscle training, aerobic exercise, and detraining in women with COPD: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Aug 8;18(1):390. doi: 10.1186/s13102-026-01964-7.

    PubMed 42687177

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory Muscle Training and Aerobic Exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mehmet İsmail TOSUN at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maximal Inspiratory Pressure (time frame: Baseline and immediately after the 4-week intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07604961, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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